On February 15, 2018, 18 Democratic members of Congress sent a letter to Health and Human Services (HHS) Secretary Alex Azar, asking him to use his authority under 28 U.S.C. §1498 to issue a compulsory license on patents for drugs that treat hepatitis C. In other words, they are demanding that the government steal a […]
Any Willing Pharmacy – Not as Good as it Sounds
On November 28, 2017, the Centers for Medicare and Medicaid Services (CMS) published a proposed rule that would revise Medicare Part D, the prescription drug program. The proposal dredges up the “any willing pharmacy” issue that would require any Part D plan sponsor, such as an insurer or a pharmacy benefit manager (PBM), to allow […]
The BBA, Medicare Part D, and a Cautionary Tale
When President Trump signed the Bipartisan Budget Act (BBA) for fiscal years 2018 and 2019 on February 9, 2018, Citizens Against Government Waste (CAGW) objected because of its prolific and irresponsible spending, calling the $300 billion (14 percent) increase over current levels “outrageous and unnecessary, as well as a complete abdication of fiscal discipline and […]
New FDA Report on BPA: It is Still Safe
On February 23, 2018, the Food and Drug Administration (FDA) released a statement by Deputy Commissioner for Foods and Veterinary Medicine Stephen Ostroff, M.D., regarding a draft report issued by the National Toxicology Program (NTP) on the compound bisphenol A, more commonly referred to as BPA. The report concluded that BPA, the compound used to […]
Trump Administration Reverses Obama-era Rule on Health Insurance
On Tuesday, February 20, the Department of Health and Human Services (HHS) released a long-awaited proposed rule that would change an Obama administration rule that curtailed short-term, limited-duration health insurance (STLDI) plans. The HHS press release stated, “In direct response to President Trump’s October 2017 Executive Order, the Departments of Health and Human Services (HHS), […]
Drug Prices – The Council of Economic Advisers and Trump Administration Weigh In
Report spotlights how imposing price controls and government regulations hamper drug approvals and slow competition.
FDA Tobacco Products Scientific Advisory Committee Weighs in on IQOS
On January 24 and 25, 2018, the Food and Drug Administration’s (FDA) nine-member Tobacco Products Scientific Advisory Committee (TPSAC) reviewed the Modified Risk Tobacco Product Applications (MRTPA) on an innovative tobacco product, named the IQOS, which is designed to reduce the harm associated with tobacco use. CAGW discussed the MRTPA and the advisory committee meeting […]
FDA Advisory Committee to Discuss New Tobacco Harm Reduction Product
The Family Smoking and Prevention and Tobacco Control Act (TCA) became law in June 2009 and gave the Food and Drug Administration (FDA) authority to regulate the manufacture, distribution, and marketing of all tobacco products. Included in the law is Section 918, which called for a report to Congress on how best to regulate, promote, […]
Taxpayers and Patients Win First Round on 340B Drug Discount Rule
On January 1, 2018, hospitals will begin to receive lower government reimbursements for drugs purchased under the 340B program.
Obamacare Enrollments Predicted to be Lower in 2018
Open season for individuals to sign up for a Patient Protection and Affordable Care Act (Obamacare) healthcare plan started on November 1, 2017 and will close Friday, December 15, 2017. With the average premium for the second-lowest cost silver plan, often called the “benchmark” plan, increasing by 37 percent for a 27-year-old, it seems likely […]